FDA 510(k) Application Details - K132547

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K132547
Device Name	Calculator, Drug Dose
Applicant	MONARCH MEDICAL TECHNOLOGIES 3457 CHISWICK COURT SILVER SPRING, MD 20906 US Other 510(k) Applications for this Company
Contact	ANN A GRAHAM Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	NDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2013
Decision Date	04/17/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review